1. Standards Coordination Office U.S. Government and Standards December 3, 2015 1

2. US Government Roles in Standards System UserSpecifierParticipant Convener AdvocateContributorAdvisorLeaderSponsor 2

3. Ways Voluntary Standards Are “Used” by Government Adoption into Regulation through Incorporation by Reference Code of Federal Regulations State and Local Adoption Decision not to Regulate - Deference Written into Federal Grant and Procurement Contracts Used in Agency Programs and Operations 3

4. Government Role as Standards User 4 In Regulation Over 13,000 citations of standards in the Code of Federal Regulations Over ¾ are non- government standards In specifying what USG will buy (procurement contracts) 1000’s of standards are used in purchasing goods

5. 5 > 10,000 Standards are Used in Regulations

6. Incorporation by Reference – FDA Part 101 – Food Labeling 21 CFR 101.4(h) 6 The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

7. Incorporation by Reference – FDA Bottled Water Rule Title 21 - Food and Drugs Volume 2 Part 165 – BEVERAGES 7

8. Government Role as Standards User – Deference to Market 8 Residential Gas Water Heater Standard ANSI Z21.10/ CSA 4.3-2004 (R2009) Residential Gas Water Heater Standard ANSI Z21.10/ CSA 4.3-2004 (R2009)

9. Unique Item Identifiers MIL SPEC 130 accepts:  ATA CSDD  ISO/IEC 15434  AIAG B-4, AIAG B-17  ANSI MH10.8.7  CEA-706, CAGE  GS1  NASA-STD Government Role as Standards User – Procurement - DoD 9

10. Government Role as Participant – Standards Development 10 Government staff participate in the standards development process:  Contribute technical expertise/resources  Ensure government needs are being met

11. > 3100 Federal Agency Staff Participated in Standards Setting Organizations in 2014 11

12. Current Legal and Policy Framework  National Technology Transfer and Advancement Act (NTTAA) - 1996  OMB Circular A-119 – Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities – 1998  Trade Agreements Act of 1979  Agency Specific Laws, Rules, and Policies 12

13. Goals of NTTAA and OMB A-119  Eliminate cost (of developing standards)  Decrease the cost of goods and burden of complying with agency regulations  Promote efficiency and economic competition through harmonization of standards  Further the reliance on the private sector to supply Government needs  Enhance collaboration with the private sector on standards that serve national needs 13

14. The NTTAA Section 12(d)(1) “… all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.”. 14

15. NTTAA Has Been Effective 15 Since reporting began in 1997:  3,579 private sector standards have replaced Government-unique standards

16. GSA Exception Government Unique Standard: Federal Specification FF-L-2937 – Combination Lock, Mechanical (Incorporated: 2006) Voluntary Standard: UL 768 Combination Locks Rationale: The lock covered by the GUS is used for the protection of classified information and weapons. The UL specification did not meet identified government needs for dialing tolerance and bolt end pressure. Government Unique Standard: Federal Specification FF-L-2937 – Combination Lock, Mechanical (Incorporated: 2006) Voluntary Standard: UL 768 Combination Locks Rationale: The lock covered by the GUS is used for the protection of classified information and weapons. The UL specification did not meet identified government needs for dialing tolerance and bolt end pressure. 16

17. Review  Federal Government is an active player and user of the private sector led standards system in the US.  Standards are used in diverse ways to support agency missions.  Various laws, policies and guidance documents provide us a framework in which to operate. 17

18. 18 Useful Links Dept. of Commercewww.commerce.govwww.commerce.gov NIST www.nist.govwww.nist.gov NCSCIwww.nist.gov/ncsciwww.nist.gov/ncsci Notify U.S.www.nist.gov/notifyuswww.nist.gov/notifyus Standards.Gov www.standards.govwww.standards.gov Regulations.Govwww.regulations.govwww.regulations.gov Export.Govwww.export.govwww.export.gov Trade.Govwww.trade.govwww.trade.gov

19. Thank You Questions? Mary Donaldson Mary.Donaldson@nist.gov 1-301-975-6197 http://www.standards.gov http://gsi.nist.gov 19